Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02047734 | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis | PHASE3 | COMPLETED | 1,320 | — | — | Dec 3, 2013 | Apr 13, 2017 | Feb 11, 2021 | 299 | United States, Belarus +19 |
| NCT01628393 | Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients | PHASE2 | COMPLETED | 258 | — | — | Sep 18, 2012 | May 11, 2016 | Feb 11, 2021 | 58 | United States, Belgium +11 |
A relapse was defined as new or worsening neurological symptoms attributable to MS and preceded by a relatively stable or improving neurological state for at least 30 days. Symptoms must have persisted for \> 24 hours and not be attributable to confounding clinical factors. Relapses were confirmed when accompanied by objective neurological worsening based on examination by the blinded evaluator, consistent with an increase of ≥ 0.5 on the overall EDSS score relative to the most recent EDSS assessment, or 2 points on one of the functional system scale scores, or 1 point on ≥ two functional system scale scores. Relapse rate was calculated as the total number of confirmed relapses divided by the total number of days in the study \* 365.25. ARR was based on a Poisson regression model, adjusted for region (Eastern Europe vs Rest of the World), age, and the Baseline number of gadolinium-enhancing lesions, and included the natural log transformation of time on study as an offset term.
The cumulative number of total GdE lesions on MRI from Week 12 to Week 24. MRI scans were assessed and scored by an independent MRI analysis center with no knowledge of treatment assignment or outcomes.
| Arm | Type | Description |
|---|---|---|
| Ozanimod 0.5 mg | EXPERIMENTAL | Ozanimod 0.5 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. |
| Ozanimod1 mg | EXPERIMENTAL | Ozanimod 1 mg oral capsules daily and a weekly intramuscular placebo injection (identical in appearance to Interferon) for 24 months. |
| Interferon β-1a | ACTIVE_COMPARATOR | interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection weekly and matching placebo capsules (identical in physical appearance to ozanimod) orally daily for 24 months. |
| Ozanimod 1 mg | EXPERIMENTAL | Participants received ozanimod 0.5 mg oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and continue to receive ozanimod 1 mg weekly for another 96 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo to ozanimod oral capsules daily for 24 weeks. Participants who completed the 24-week treatment period had the option to enter the blinded extension period and were randomized to receive ozanimod 0.5 mg or 1 mg weekly for 96 weeks. |
| Name | Type | Description |
|---|---|---|
| Ozanimod | DRUG | Oral capsule, daily for 24 months |
| Ozanimod placebo | DRUG | Oral capsule, daily for 24 months |
| Interferon beta-1a | DRUG | Intramuscular injection, 30 µg, weekly for 24 months |
| Interferon beta-1a placebo | DRUG | Intramuscular injection, weekly for 24 months |
| Placebo | DRUG | Oral capsule taken once a day |
Inclusion Criteria: * Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria * Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline Exclusion Criteria: * Primary progressive multiple sclerosis